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This study aimed to evaluate the oral stereognosis in completely edentulous patients with palatal tori. Oral stereognosis is tested using different test specimens in completely edentulous patients with maxillary tori and completely edentulous patients without maxillary tori.
Oral Stereognosis has been defined as appreciation of the form of objects that is explored intra-orally. In this study the oral stereognosis is determined by placing objects of various shapes in the patient's mouth and having the patient identify the correct form. Several studies has proved that oral stereognosis ability (OSA) can be used as a predictor for determining the ability of the patients with missing teeth to adapt to a new prosthesis placed in the patient's mouth.
Maxillary tori is a non-cancerous bony swelling found in palate and have high prevalence among Malaysian population. Whether OSA is higher or lower in patients with maxillary tori is not known.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| completely edentulous patients with maxillary tori | Experimental | 20 completely edentulous patients with maxillary tori will be recruited for the study. The oral stereognosis will be evaluated by oral stereognostic test which employs manipulation and identification 6 different test pieces when placed in the patients mouth. |
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| completely edentulous patients without maxillary tori | Active Comparator | 20 completely edentulous patients without maxillary tori will serve as control group for the study. The oral stereognosis will be evaluated by oral stereognostic test which employs manipulation and identification 6 different test pieces when placed in the patients mouth. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral stereognostic test | Other | Six test pieces were selected from the 20 shapes of test pieces from National Institute of Dental Research. The test pieces comprises of 6 shaped forms which include circle, plus, square, rectangular, triangle and toroid shaped. A 2mm stainless steel wire was bent forming the test piece shape following the standard dimensions (13mm length and 2mm thickness)as described by National Institute of Dental Research to serve as the test pieces mould. Using the six test piece moulds, light cured acrylic resin test samples were fabricated. The test samples were trimmed and polished to meet the standardized measurements. A total of 240 test sample (6 samples for each patient) for 20 completely edentulous patients with maxillary tori and 20 completely edentulous patients without tori were made for the study. The test pieces were attached to dental floss to prevent any accidentally aspiration during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the oral stereognosis | Oral stereognosis test will be performed using test pieces will be placed intraorally and patients will be instructed to identify the shape of test pieces with their tongue and palate. A visual representation chart of all 6 shaped forms will be provided to patient for identification purpose. Patients will be asked to identify the correct shape form by pointing out on the corresponding shape form on the chart. The 6 test pieces will be presented randomly to the patients and correct answer will not be informed to the patients during the OSA. The duration time for recognition of each shaped form for each patient will be noted and answers will be recorded on an OSA evaluation form. A correct answer will recorded as one point and incorrect answer is zero point. A full 6 points will be scored if all answers were correct. The response time and the OSA scores will be recorded. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Indumathi Sivakumar, MDS | Senior Lecturer, Faculty of Dentistry, SEGi University, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, SEGi University | Petaling Jaya | Selangor | 47410 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17441875 | Background | Ikebe K, Amemiya M, Morii K, Matsuda K, Furuya-Yoshinaka M, Nokubi T. Comparison of oral stereognosis in relation to age and the use of complete dentures. J Oral Rehabil. 2007 May;34(5):345-50. doi: 10.1111/j.1365-2842.2007.01687.x. | |
| 28367901 | Result | Park JH. Changes in oral stereognosis of healthy adults by age. J Oral Sci. 2017;59(1):71-76. doi: 10.2334/josnusd.16-0366. |
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The data pertaining to oral stereognosis scores obtained by the participants and the response time duration for completing the test would be shared.
Data will be available from February 2020
Researchers in this field of study who request data for multicentric study comparison. Data access request will be reviewed by a panel of reviewers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 17, 2018 | Jan 28, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| C566043 | Torus Palatinus and Torus Mandibularis |
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| 9578225 | Result | Mantecchini G, Bassi F, Pera P, Preti G. Oral stereognosis in edentulous subjects rehabilitated with complete removable dentures. J Oral Rehabil. 1998 Mar;25(3):185-9. doi: 10.1046/j.1365-2842.1998.00221.x. |